ARTICLE | Company News

Hospira, Orion, Novartis neurology news

October 13, 2014 7:00 AM UTC

Orion, Hospira and Novartis' Sandoz Inc. and Sandoz Canada Inc. units amended a December 2013 agreement to allow Sandoz rights to immediately launch a generic version of Precedex dexmedetomidine. Under the original agreement, Sandoz had rights to launch the generic on Dec. 26, 2014, or earlier under undisclosed criteria, to settle a 2009 lawsuit with Sandoz Inc. The suit alleged that Sandoz's ANDA for a generic version of neurology drug Precedex infringed Orion's U.S. Patents Nos. 4,910,214 and 6,716,867 (see BioCentury, Dec. 16, 2013).

The amendment follows a September decision by the U.S. District Court for the District of Maryland siding with FDA in a separate suit challenging whether the agency could approve generic versions of a sedative so long as the generic labels do not include an approved use covered by a method of use patent. The district court decision cleared the way for the U.S. launch of two dexmedetomidine generics that FDA approved in August, when the agency simultaneously said it had the authority to approve the generics. Hospira is appealing the decision (see BioCentury, Sept. 15). ...